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510(k) K914295

ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED by Bruel & Kjaer — Product Code CBQ

K914295 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer for the device "ANESTHETIC GAS MONITOR TYPE 1304, MODIFIED". The FDA issued a decision of Substantially Equivalent on April 10, 1992. The device falls under product code CBQ (Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)), a Class II device regulated under 21 CFR 868.1500. Bruel & Kjaer has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 1992
Date Received
September 9, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
Device Class
Class II
Regulation Number
868.1500
Review Panel
AN
Submission Type

Other clearances by Bruel & Kjaer

  • K925484 — CARBON DIOXIDE & OXYGEN MONITOR TYPE 1308 (June 22, 1993)
  • K905198 — DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 (August 28, 1991)
  • K911348 — RIGID ENDOSCOPE (June 21, 1991)

Other clearances for product code CBQ

  • K040917 — PHILIPS ANESTHESIA GAS MONITOR, MODEL M1026B (April 29, 2004)
  • K994188 — MODIFICATION TO AGILENT TECHNOLOGIES ANESTHESIA GAS MONITOR, MODEL M1026A #CO5 (May 19, 2000)
  • K962648 — OHMEDA MODEL 5330 ANESTHETIC AGENT MONITOR (January 17, 1997)
  • K931439 — OHMEDA MODEL 5330 ANESTHETIC MONITOR (October 19, 1993)
  • K926451 — DATASCOPE MULTINEX II (August 25, 1993)
  • K923433 — AS/3 ANAESTHESIA MONITORING SYSTEM AIRWAY MODULE (July 22, 1993)
  • K922876 — AS/3 COP MODULE (July 21, 1993)
  • K923276 — CAPNOMAC ULTIMA ANESTHESIA MONITOR (July 21, 1993)
  • K930303 — DATASCOPE MULTINEX ID PLUS (June 16, 1993)
  • K911644 — NGM FRAME (March 4, 1992)

FDA data resources